The study will evaluate if DP-VPA, a derivative of valproate (a drug that is commonly used for the prevention of migraine attacks), can reduce the rate of migraine attacks. Migraine patients will take DP-VPA or placebo (an inactive look-alike drug) every morning and will have to report any migraine attacks they have during the study's 18-week follow up.
The multi-center trial has a double-blind, randomized, placebo-controlled, parallel-group design and will be carried out in Israel. Approximately 40 adult subjects with migraine will be randomly assigned (1:1) to either DP-VPA (maximum of 900mg/day) or placebo. Active and placebo will be administered orally and once-daily on an add-on basis, i.e. other permissible ongoing medications will be continued. Total study duration per subject will be 18 weeks. Subjects will report on their migraine attacks frequency and other attack characteristics using weekly diaries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
DP-VPA dose escalation to 900mg, then continued for 8 weeks
Matching Placebo to Active, dose escalation, then continued for 8 weeks
Rambam Medical Center
Haifa, Israel
Bnei Zion Medical Centre
Haifa, Israel
Wolfson Medical Center
Holon, Israel
Beilinson Medical Centre
Petah Tikva, Israel
Migraine attacks frequency
Time frame: 6 months
Migraine days
Time frame: 6 months
Responders (subjects with >50% decrease in migraine frequency)
Time frame: 6 months
Triptan consumption
Time frame: 6 months
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Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Chaim Sheba Medical Center
Tel Litwinsky, Israel